BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12033514 · Received June 21, 2021

    Report

    Report Number
    3004932373-2021-00297
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 11, 2021
    Report Date
    August 17, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    YOUR FACILITY PROVIDED PHOTO TO AID IN OUR QUALITY ENGINEER¿S INVESTIGATION. WITH THE PHOTO PROVIDED, BD WAS ABLE TO CONFIRM THE FAILURE MODE AS IT SHOWS THE END CAP DETACHED AND GLASS ENDED UP ON THE FLOOR. A DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT 0327867. THE ROOT CAUSE IS ATTRIBUTED TO THE EQUIPMENT STATION FOR THE END CAP PLACEMENT UNTO THE APPLICATOR BODY. CORRECTIVE ACTIONS WERE INITIATED WHICH LED TO BD CONDUCTING A VOLUNTARY RECALL ON CERTAIN LOTS OF THE CHLORAPREP HI-LITE ORANGE 26 ML APPLICATOR. BD HAS CONFIRMED THAT SOME OF THE PRODUCT, WHICH INCLUDED THIS LOT, HAD AN APPLICATOR END CAP THAT WAS IMPROPERLY SECURED DURING THE MANUFACTURING PROCESS WHICH RESULTED IN BROKEN GLASS DROPPING OUT OF THE APPLICATOR. YOUR FACILITY SHOULD HAVE RECEIVED A RECALL NOTIFICATION FOR THIS FAILURE, AND IT IS ALSO ATTACHED TO THIS EMAIL. PLEASE ENSURE THAT YOUR FACILITY COMPLETES THE CUSTOMER RESPONSE FORM ASSOCIATED WITH THE RECALL AND FOLLOWS THE DIRECTIONS PROVIDED. BD RECOGNIZES THAT CUSTOMERS PLACE THEIR TRUST IN OUR PRODUCTS, AND WE STRIVE TO EXCEED THE EXPECTATIONS OF EVERY CUSTOMER. YOUR FEEDBACK IS ESSENTIAL TO OUR MISSION TO IMPROVE THE PRODUCTIVITY AND SAFETY OF HEALTH CARE GLOBALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE AMPULE FELL OUT AND SHATTERED. PER EMAIL: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING CHLORAPREP AMPULE FELL OUT AND SHATTERED. A PHOTO WAS RECEIVED AS A SAMPLE AND THE REPORTED ISSUE HAS BEEN CONFIRMED, PLEASE SEE ATTACHED PHOTOS. WE WANT TO ENSURE THAT YOU ARE AWARE OF THIS ISSUE AND WE DO REQUIRE A RESPONSE AT THIS TIME. THERE ARE NO SAMPLES CURRENTLY AVAILABLE TO RETURN AT THIS TIME, WE WILL REACH OUT TO YOU IF A SAMPLE BECOMES AVAILABLE AT A FUTURE TIME. PLEASE REFERENCE THE COMPLAINT NUMBER BELOW IN ALL FUTURE COMMUNICATION, FOR DOCUMENTATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE AMPULE FELL OUT AND SHATTERED. PER EMAIL: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING CHLORAPREP AMPULE FELL OUT AND SHATTERED. A PHOTO WAS RECEIVED AS A SAMPLE AND THE REPORTED ISSUE HAS BEEN CONFIRMED, PLEASE SEE ATTACHED PHOTOS. WE WANT TO ENSURE THAT YOU ARE AWARE OF THIS ISSUE AND WE DO REQUIRE A RESPONSE AT THIS TIME. THERE ARE NO SAMPLES CURRENTLY AVAILABLE TO RETURN AT THIS TIME, WE WILL REACH OUT TO YOU IF A SAMPLE BECOMES AVAILABLE AT A FUTURE TIME. PLEASE REFERENCE THE COMPLAINT NUMBER BELOW IN ALL FUTURE COMMUNICATION, FOR DOCUMENTATION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928110 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0327867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other